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Clinical Trials/NCT06307977
NCT06307977
Recruiting
Not Applicable

Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples

Hunter College of City University of New York3 sites in 1 country360 target enrollmentMay 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use
Sponsor
Hunter College of City University of New York
Enrollment
360
Locations
3
Primary Endpoint
Urine assay for drug use
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).

Registry
clinicaltrials.gov
Start Date
May 25, 2024
End Date
February 2029
Last Updated
10 months ago
Study Type
Interventional
Study Design
Factorial
Sex
Male

Investigators

Sponsor
Hunter College of City University of New York
Responsible Party
Principal Investigator
Principal Investigator

Tyrel Starks

Professor

Hunter College of City University of New York

Eligibility Criteria

Inclusion Criteria

  • Have a main partner who is another cisgender male and have been in a relationship for 3 month or longer
  • Index participant must be between 18 and 55; Main partner can be any age 18 and older
  • One participant must be HIV negative (as confirmed by rapid test)
  • One participant must have used at least 1 drug in the past 30 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB, amyl nitrite)
  • Index participant must have engaged in TRB in the past 30 days- Defined as CAS with a casual partner, or a serodiscordant or non-monogamous main partner
  • Live in the United States
  • Speak and read English
  • Exclusion Criteria
  • Any signs of serious mental illness or cognitive deficit
  • Current suicidal/homicidal ideations

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Urine assay for drug use

Time Frame: 9 Months

Positive urine screen for drug use assessed bi-annually

Drug use Frequency

Time Frame: 9 Months

Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments

CAS with casual partners

Time Frame: 9 Months

Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments in the absence of adequate PrEP coverage

Secondary Outcomes

  • Bacterial sexually transmitted infections(9 Months)
  • Binge Drinking(9 Months)
  • PrEP Uptake(9 months)

Study Sites (3)

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